Baxter recieves warning letter from FDA

The Office of Compliance and Biologics Quality (OCBQ) in the FDA's Center for Biologics Evaluation and Research (CBER) has sent a warning letter to Baxter regarding the company's promotional material for Tisseel general surgery brochure.

The OCBQ claims that the presentation, brochure and sell sheet are false or misleading because these materials, among other things, overstate the efficacy of Tisseel and make unsubstantiated claims of superiority for Tisseel over other conventional hemostatic agents. The OCBQ asked Baxter to cease the dissemination of “violative” promo material for Tisseel.